TEAM-Red, a Remotely Delivered Self-management Program for Depressed Black Women at Risk for Hypertension (TEAM-Red)

April 23, 2026 updated by: Jennifer B. Levin

A Pilot RCT of a Remotely Delivered Self-management Program (TEAM-Red) for Depressed Young African American Women at Risk for Hypertension (HTN)

The proposed project is a 24-week prospective randomized controlled trial (RCT) evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=41) vs. enhanced waitlist (eWL, N=41) control in young (<50 years) African American women who are depressed or suffering from stress, and at risk for hypertension.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Description

Phase 1 Inclusion Criteria:

  1. Registered on Research Goes Red;
  2. Self-identified African American female ages 18-49;
  3. current depression as measured by a score of ≥10 on the 9-item Patient Health Questionnaire (PHQ-9),
  4. Have at least one of the following self or chart-recorded HTN risk factors: body mass index (BMI) greater ≥ 30, HbA1c >5.75, at least one outpatient reading of systolic blood pressure (BP) ≥ 130 mm Hg or diastolic ≥90 mmHg, current smoker, or LDL ≥100 mg/dl in the last 12 months;
  5. Are able to participate in study procedures.

Phase 1 Exclusion Criteria:

  1. Unwilling/unable to provide informed consent;
  2. Pregnancy;
  3. Imminent suicide risk,
  4. A current diagnosis of hypertension or use of antihypertensive medications.

Phase 2 Inclusion Criteria

  1. Self-identified AA female ages 18-49;
  2. Endorses either: a past or current history of depression, current depression as measured by a score of at least a 5 on the 9-item Patient Health Questionnaire (PHQ-9), or indicate feelings of stress or discrimination that impact their functioning
  3. Have at least one of the following self or chart-recorded HTN risk factors: BMI greater ≥ 30,26 HbA1c >5.75,27 at least one outpatient reading of systolic BP ≥ 130 mm Hg or diastolic ≥90 mmHg, current smoker, or LDL ≥100 mg/dl in the last 12 months;
  4. Are able to participate in study procedures.

Phase 2 Exclusion Criteria

  1. Unwilling/unable to provide informed consent;
  2. Pregnancy;
  3. Imminent suicide risk,
  4. A current diagnosis of HTN or use of antihypertensive medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TEAM-Red
Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference
Behavioral: TEAM-Red
Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference
Other: Enhanced Waitlist (eWL)
After the week 12 follow up visit, subjects in the Waitlist group will receive the TEAM Red intervention
Other: Waitlist
After the week 12 follow up visits subjects in the Waitlist group will receive the TEAM Red intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase 1 TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up
Time Frame: Baseline to 12 weeks
PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression
Baseline to 12 weeks
Phase 1 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow up
Time Frame: Baseline to 24 weeks
PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression
Baseline to 24 weeks
Phase 2 TEAM-Red vs eWL 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up
Time Frame: Baseline to 12 weeks
PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression
Baseline to 12 weeks
Phase 2 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow-up
Time Frame: Baseline to 24 weeks
PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression
Baseline to 24 weeks
Phase 2 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up
Time Frame: Baseline to 12 weeks
PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
Baseline to 12 weeks
Phase 2 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up
Time Frame: Baseline to 24 weeks
PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
Baseline to 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Phase 1 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up
Time Frame: Baseline to 12 weeks
PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
Baseline to 12 weeks
Phase 1 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up
Time Frame: Baseline to 24 weeks
PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
Baseline to 24 weeks
Phase 1 TEAM-Red vs eWL 12-item Short Form Survey (SF-12) mental component score at 12-week follow up
Time Frame: Baseline to 12 weeks
SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health
Baseline to 12 weeks
Phase 1 TEAM-Red vs eWL 12-item Short Form Survey (SF-12) physical component score at 12-week follow up
Time Frame: Baseline to 12 weeks
SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health
Baseline to 12 weeks
Phase 1 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up
Time Frame: Baseline to 24 weeks
SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health
Baseline to 24 weeks
Phase 1 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up
Time Frame: Baseline to 24 weeks
SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health
Baseline to 24 weeks
Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) mental component score at 12-week follow-up
Time Frame: Baseline to 12 weeks
SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health
Baseline to 12 weeks
Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) physical component score at 12-week follow-up
Time Frame: Baseline to 12 weeks
SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health
Baseline to 12 weeks
Phase 2 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up
Time Frame: Baseline to 24 weeks
SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health
Baseline to 24 weeks
Phase 2 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up
Time Frame: Baseline to 24 weeks
SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health
Baseline to 24 weeks
Phase 1 and Phase 2 TEAM-Red vs eWL change in 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up
Time Frame: Baseline to 12 weeks
PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression
Baseline to 12 weeks
Phase 1 and Phase 2 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow up
Time Frame: Baseline to 24 weeks
PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression
Baseline to 24 weeks
Phase 1 and Phase 2 TEAM-Red vs eWL change in 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up
Time Frame: Baseline to 12 weeks
PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
Baseline to 12 weeks
Phase 1 and Phase 2 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up
Time Frame: Baseline to 24 weeks
PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
Baseline to 24 weeks
Phase 1 and Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) mental component score at 12-week follow-up
Time Frame: Baseline to 12 weeks
SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health
Baseline to 12 weeks
Phase 1 and Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) physical component score at 12-week follow-up
Time Frame: Baseline to 12 weeks
SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health
Baseline to 12 weeks
Phase 1 and Phase 2 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up
Time Frame: Baseline to 24 weeks
SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health
Baseline to 24 weeks
Phase 1 and Phase 2 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up
Time Frame: Baseline to 24 weeks
SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health
Baseline to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jennifer B. Levin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Heart Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Levin, University Hospitals Cleveland Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 18, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY20220976

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data with the data dictionary and protocol will be made available to other researchers via the American Heart Association (AHA) Precision Medicine Platform

IPD Sharing Time Frame

Data will be available by one year following the funding

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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